Full Press Release Details
Silverback Therapeutics Reports Third Quarter 2021 Financial Results and Provides Business Update
SEATTLE November 10, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ( Silverback ), a
clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases,
today reported financial results for the third quarter ended September 30, 2021 and provided a business update.
In the third quarter, we
provided our first interim clinical update for the dose escalation arms of the SBT6050-101 trial, establishing proof-of-mechanism
for SBT6050 as evidenced by the activation of the innate and adaptive immune system in patients, said Laura Shawver, Ph.D., chief executive officer of Silverback. In a short period of time, we have accumulated a robust clinical data set
that has informed our development strategy. We are focused on advancing SBT6050 in patients with HER2-expressing cancers such as gastroesophageal and non-small cell lung, in combination with agents that we
believe will maximize the therapeutic potential of our first-in-class TLR8 agonist conjugate. We also look forward to continuing to advance our pipeline, including
SBT6290 for patients with bladder, triple negative breast, non-small cell lung, and head & neck cancers, and SBT8230 for patients with chronic hepatitis B virus.
Recent Business Updates:
SBT6050 (HER2-TL8 ImmunoTAC)
(Nectin4-TL8 ImmunoTAC)
SBT8230 (ASGR1-TLR8 ImmunoTAC for chronic HBV)
Third Quarter Financial Results
For the third quarter ended September 30, 2021, Silverback reported a net loss of $22.7 million, compared to a net loss of $8.1 million for the
comparable period in 2020. For the nine months ended September 30, 2021, Silverback reported a net loss of $66.0 million, compared to a net loss of $19.9 million for the comparable period in 2020. Included in the net losses for the
three and nine months ended September 30, 2021 were $5.0 million and $14.0 million of non-cash stock-based compensation, respectively, compared to $0.2 million and $0.4 million for the
same periods in 2020, respectively.
Research and development expenses for the third quarter ended September 30, 2021 were $15.6 million,
compared to $6.2 million for the same period in 2020. Research and development expenses for the nine months ended September 30, 2021 were $45.6 million compared to $15.7 million for the same period in 2020. The increases in the
Company s research and development expenses in 2021 were primarily attributable to the advancement of pipeline programs, including SBT6290 and SBT8230, through preclinical development and the continued clinical development of SBT6050.
Silverback also incurred additional personnel-related expenses as operations grew in support of program advancements.
General and administrative expenses
for the third quarter ended September 30, 2021 were $7.0 million, compared to $1.9 million for the same period in 2020. General and administrative expenses for the nine months ended September 30, 2021 were $20.4 million,
compared to $4.1 million for the same period in 2020. The increases in general and administrative expenses were primarily attributable to an increase in personnel-related expenses due to increased headcount in 2021, including new executives, as
well as increases in salaries, bonuses, and stock-based compensation. The increases in general and administrative expenses were also due to an increase in legal fees, professional fees, and other various general and administrative expenses as we now
operate as a public company.
As of September 30, 2021, Silverback reported cash, cash equivalents, and investments of $340.6 million compared
to cash and cash equivalents of $386.6 million at December 31, 2020, which is expected to fund operating expenses and capital expenditure requirements into 2024.
About Silverback Therapeutics
Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered and tissue targeted therapeutics for the treatment of cancer, chronic viral
infections, and other serious diseases. Silverback s platform enables the strategic pairing of proprietary payloads that modulate key disease modifying pathways with monoclonal antibodies directed at specific disease sites. Initially,
Silverback is creating a new class of targeted immuno-oncology agents that direct a TLR8 agonist myeloid cell activator to the tumor microenvironment in solid tumors to promote cancer cell killing. Silverback Therapeutics is located
in Seattle, Washington. To learn more, visit www.silverbacktx.com.
Forward-Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different
from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, Silverback s plans and ability to bring new treatments
to patients in need, including potential combination efforts, the progress and expected timing of Silverback s drug development programs and clinical trials, and the strength of Silverback s balance sheet and the adequacy of cash on hand.
Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the
risk that Silverback may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings and applications, risks associated with reliance on third parties to successfully conduct
clinical trials, the risks associated with reliance on outside financing to meet capital requirements, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human
therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words may, will, would, could, should,
believes, estimates, projects, promise, potential, expects, plans, anticipates, intends, continues, designed,
goal, or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties that Silverback faces, please refer to Silverback s periodic and
other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Silverback assumes no obligation to update any
forward-looking statements, whether as a result of new information, future events or otherwise.
Silverback Therapeutics
Canale Communications
Silverback Therapeutics, Inc.
Condensed Balance Sheets
(in thousands, except share and par value data)
| September 30, 2021 | December 31, 2020 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 300,660 | $ | 386,569 | ||||
| Prepaid expenses and other current assets | 4,695 | 4,087 | ||||||
| Total current assets | 305,355 | 390,656 | ||||||
| Investments | 39,938 | |||||||
| Restricted cash | 350 | 350 | ||||||
| Right-of-use asset | 5,011 | 2,180 | ||||||
| Property and equipment, net | 1,907 | 1,618 | ||||||
| Total assets | $ | 352,561 | $ | 394,804 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,720 | $ | 2,583 | ||||
| Accrued expenses | 12,537 | 5,278 | ||||||
| Term loan payable, net | 844 | |||||||
| Current portion of lease liability | 1,090 | 896 | ||||||
| Total current liabilities | 15,347 | 9,601 | ||||||
| Lease liability, net of current portion | 5,080 | 2,326 | ||||||
| Total liabilities | 20,427 | 11,927 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity: | ||||||||
| Preferred Stock, $0.0001 par value per share; 10,000,000 shares authorized at September 30, 2021 and December 31, 2020; no shares issued and outstanding at September 30, 2021 and December 31, 2020 | ||||||||
| Common stock, $0.0001 par value per share; 200,000,000 shares authorized at September 30, 2021 and December 31, 2020, 35,067,751 and 34,801,537 shares issued and 35,037,136 and 34,701,274 shares outstanding at September 30, 2021 and December 31, 2020, respectively | 4 | 3 | ||||||
| Additional paid-in capital | 494,916 | 479,608 | ||||||
| Accumulated other comprehensive loss | (34 | ) | ||||||
| Accumulated deficit | (162,752 | ) | (96,734 | ) | ||||
| Total stockholders equity | 332,134 | 382,877 | ||||||
| Total liabilities, and stockholders equity | $ | 352,561 | $ | 394,804 |
Silverback Therapeutics, Inc.
Condensed Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 15,641 | $ | 6,200 | 45,630 | $ | 15,740 | |||||||||
| General and administrative | 7,040 | 1,912 | 20,447 | 4,077 | ||||||||||||
| Total operating expenses | 22,681 | 8,112 | 66,077 | 19,817 | ||||||||||||
| Loss from operations | (22,681 | ) | (8,112 | ) | (66,077 | ) | (19,817 | ) | ||||||||
| Interest income (expense), net | 26 | (4 | ) | 59 | (45 | ) | ||||||||||
| Net loss | $ | (22,655 | ) | $ | (8,116 | ) | (66,018 | ) | $ | (19,862 | ) | |||||
| Unrealized gain (loss) on available-for-sale securities | (34 | ) | (34 | ) | ||||||||||||
| Comprehensive loss attributable to common stockholders | $ | (22,689 | ) | $ | (8,116 | ) | (66,052 | ) | $ | (19,862 | ) | |||||
| Net loss per share applicable to common stockholders, basic and diluted | $ | (0.65 | ) | $ | (11.97 | ) | $ | (1.89 | ) | $ | (29.53 | ) | ||||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 35,001,466 | 678,048 | 34,884,656 | 672,531 |